Biosimilars guidelines: A step in the right direction for India

Commenting on the challenges that the industry will face with the new regulations, Mr William Lee of Quintiles Asia says, "The Indian guidelines are not too dissimilar from the EU and WHO guidelines and the draft US guidelines. As these international guidelines are widely available and have been used for several years, most Indian biopharmaceutical companies are likely to be familiar with them. A major difference between the Indian guidelines and that of the international guidelines referred above is that there is no data exclusivity for first-approved products. This could lead to a situation where companies might get into patent related battles as there is lack of clarity in terms of data exclusivity."

Mr Subramaniam says the balance between "the requirement of supporting data and time allotted for obtaining marketing authorization encapsulated in the guidelines enables to provide an environment conducive to companies to manufacture drugs at an affordable cost benefiting the larger patient population".

"Overall, despite their limitations, these set of guidelines have come up as a relief to the industry. The fact that the regulatory requirements are more or less at par with that of the international regulatory agencies (including ICH and USFDA), would make it much easier for the Biopharmaceutical Manufacturers of India to meet the international quality standards," said Dr Ashok Kumar. "We believe that the presence of a lucid framework would surely expedite the development of Biosimilars in India that had been dawdling for want of a clear blueprint."

The guidelines will bring Indian biosimilars players at par with global biosimilar players, which could lead the way to a bigger playing field for the industry in the coming years. Also, this creates a clear pathway for the development of cost-effective and safe biologics for the people of India, which fits in with the government's agenda of more affordable healthcare. "I do believe that the Indian guidelines are a step in the right direction and will evolve with more clarity in the next couple of years," says Mr Lee.